Study Stopped
The benefit/risk profile does not support continuation of this study.
A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)
1 other identifier
interventional
5
1 country
19
Brief Summary
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 4, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2012
CompletedNovember 19, 2019
November 1, 2019
9 months
November 4, 2011
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse events
4 to 6 weeks
Secondary Outcomes (1)
To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.
18 months
Study Arms (4)
Cohort 1
EXPERIMENTAL25 mg daily for 4 weeks (8 active/2 control)
Cohort 2
EXPERIMENTAL50 mg once daily for 4 weeks (8 active/2 control)
Cohort 3
EXPERIMENTAL100 mg daily for 6 weeks (8 active/2 control)
Cohort 4
EXPERIMENTAL100 mg twice daily for 6 weeks (8 active/2 control)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
- Good health as assessed by Investigator
- DLE for at least 16 weeks prior to screening and consistent histological findings.
- Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
- Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
- Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
- Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
- Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.
You may not qualify if:
- Significant illnesses as determined by physician.
- History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
- Systolic blood pressure \< 95 or \> 150 mm Hg
- Diastolic blood pressure \> 90 mm Hg.
- Pregnancy or breast feeding.
- Other dermatological conditions that would interfere with CLASI Activity Score assessments.
- History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
- Clinically significant abnormality on chest X-ray.
- Participation in multiple CC-930 cohorts.
- History of thrombolytic event.
- Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
- Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
- Diagnosis of SLE.
- Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
- History of seizures, chorea or psychosis.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (19)
UAB Dermatology
Birmingham, Alabama, 35233, United States
The Regents of the University of California
Irvine, California, 92697, United States
Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Advanced Pharma, CR, LLC
Miami, Florida, 33136, United States
University of Miami - Department of Dermatology
Miami, Florida, 33136, United States
Rush Medical Center
Chicago, Illinois, 60612, United States
North Shore University Health System
Skokie, Illinois, 60077, United States
SIU School of Medicine
Springfield, Illinois, 62702, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
John Hopkins University
Baltimore, Maryland, 21205, United States
Boston Cancer Center
Boston, Massachusetts, 02118, United States
University of Minnesota-Department of Dermatology
Minneapolis, Minnesota, 55455, United States
University of Rochester Medical Center
Rochester, New York, 14623, United States
Ohio State Univ Medical Center, Division of Dermatology
Columbus, Ohio, 43221, United States
Rhode Island Hospital University Dermatology, Inc.
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Dermatology and Research
Dallas, Texas, 75230, United States
University of Texas Dermatology
Houston, Texas, 77030, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Smith, MD
Celgene
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2011
First Posted
November 8, 2011
Study Start
November 1, 2011
Primary Completion
July 30, 2012
Study Completion
July 30, 2012
Last Updated
November 19, 2019
Record last verified: 2019-11